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Friday, December 14, 2018

Eczema biotech Hoth Therapeutics decreases proposed IPO deal size


Hoth Therapeutics, which is developing topical treatments for eczema, lowered the proposed deal size for its upcoming IPO on Friday.
The New York, NY-based company now plans to raise $8 million by offering 1.3 million shares at a price range of $5.50 to $6.50. The company had previously filed to offer 1.8 million shares at the same range. At the midpoint of the range, Hoth Therapeutics will raise 29% less in proceeds than previously anticipated.
Hoth Therapeutics was founded in 2017 and plans to list on the Nasdaq under the symbol HOTH. Laidlaw & Company (UK) is the sole bookrunner on the deal.

Battle between Molinas forces thousands to switch doctors


Molina Healthcare is kicking former CEO Dr. J. Mario Molina’s medical practice out of its network, forcing roughly 78,000 patients to either find new doctors or switch health plans to keep their current ones.
After Dr. Molina was pushed out as CEO in 2017, he bought up Molina Healthcare’s California primary-care clinics and rebranded them as Golden Shore Medical Group. The insurance company had planned to shut the clinics down to focus on insurance as part of an organization-wide overhaul to increase its margins.
Molina Healthcare’s current contract with Golden Shore Medical expires at the end of January and the insurer doesn’t plan to renew it. A Molina Healthcare spokeswoman said the decision is the result of Golden Shore’s “substantial financial losses” that have put it under a corrective action plan with the California Department of Managed Health Care, as well as “an insupportable out-of-market rate increase.”
Dr. Molina, however, said the company’s animosity toward him is driving the decision. When he and his brother John Molina, who was the insurer’s chief financial officer, were unexpectedly ousted from the family business, Dr. Molina and many others speculated it had something to do with his advocacy for the Affordable Care Act and outspokenness against Republican repeal efforts. At the time, he was one of the only healthcare CEOs publicly criticizing the Trump administration.
Still, equity analysts say Molina’s profit margins had been well below those of other health insurers. The company recorded a loss of $512 million in 2017 but has been bouncing back. In the nine months ended Sept. 30, Molina posted profit of $506 million, compared with a loss of $250 million during the same period in 2017.
This isn’t the first contract fight between Molina Healthcare and its former CEO. Securing Golden Shore’s 2018 contract wasn’t easy, and it ended with Golden Shore being “grossly underpaid” for the patients it serves, Dr. Molina said. That led to losses—north of $20 million in 2018.
Dr. Molina said Golden Shore asked for rates to better reflect the costs of its mostly Medicaid patient population, many of whom are on dialysis, but was rejected. Dialysis utilization in Sacramento was four times what Golden Shore expected, and in Southern California it was two times what the medical group expected, he said.
“I am concerned because our patients will face disruptions in their care,” Dr. Molina wrote in a blog post on LinkedIn. “They will have to establish relationships with new doctors and leave doctors who, in some cases, have cared for their families across multiple generations. As a percentage of our patients, we are caring for some of the sickest, most medically complex people in California. Disrupting their care will disrupt the quality of their health.”
Molina Healthcare said it is working with the state to ensure members have a smooth transition to new doctors, effective Feb. 1.
Dr. Molina said it’s common for growing medical groups to fall out of compliance with state solvency requirements. Two of the medical groups that Molina Healthcare proposed moving Golden Shore patients to—Vantage Medical Group and Allied Physicians of California—have also been under corrective action plans, he said. Molina Healthcare did not confirm that patients were being transitioned to physicians with those medical practices.
California requires any risk-bearing medical organizations to maintain positive tangible net equity and working capital. It also requires organizations to keep a cash-to-claims ratio of more than 75%, process 95% of claims within 45 working days, and document the estimated incurred but not reported claims. Compliance with these measures, which are reported quarterly, are meant to help the department ensure providers are solvent.
Golden Shore Medical fell out of compliance with the tangible net equity and working capital requirements, according to documents posted on the California Department of Managed Health Care’s website, but Dr. Molina said the medical group is back in compliance today. As of June 30, 8% of the state’s 188 risk-bearing providers were not compliant with solvency requirements, up from 6% at the end of the first quarter 2018, according to the department.
The vast majority of Golden Shore’s patients are Molina Healthcare members, because for decades the clinics were owned by the insurance company. About 92% are having to switch doctors because of the dispute, but Dr. Molina worried they aren’t being given enough notice to make a decision.
Golden Shore is beginning a campaign to keep as many patients as it can by notifying patients that they will have to change plans if they want to keep their current doctors. Medicaid patients in California can switch insurers at any time, for any reason. Golden Shore also has contracts with Aetna, L.A. Care Health Plan, Health Net and Inland Empire Health Plan.

Supernus announces FDA approval of sNDA for Oxtellar XR


Supernus Pharmaceuticals announced that the United States FDA has approved the company’s supplemental new drug application for Oxtellar XR. The application requested FDA approval to expand the indication for Oxtellar XR beyond the current indication of adjunctive therapy in the treatment of partial-onset seizures in adults and in children 6 to 17 years of age.
https://thefly.com/landingPageNews.php?id=2837565

AbbVie shows allure of pharma stock buybacks


  • AbbVie’s board of directors has authorized the pharma to spend an additional $5 billion on stock buybacks, the company said Thursday, bringing the total amount newly allocated to repurchasing shares to $15 billion.
  • Through a $10 billion buyback program authorized in February, AbbVie has bought back 83.2 million shares for $8.5 billion over the first nine months of 2018. Adding in the value of shares repurchased under an earlier program, and the sum AbbVie’s spent this year on buybacks climbs to nearly $10 billion.
  • AbbVie’s not alone among pharma in its attraction to buybacks. Following the recent overhaul of the U.S. tax code, many large drugmakers newly flush with repatriated earnings have turned to the strategy to return cash to shareholders and prop up stock prices.
Stock buybacks have a number of different uses for large companies seeking ways to deploy cash. Reducing the number of outstanding shares, in theory, can increase the value of the fewer remaining shares publicly traded. That can have knock-on effects for key metrics that companies and investors play close attention to, like earnings per share.
But buybacks are also a lightning rod for criticism in biotech and pharma, as the industry is finding to be the case this year.
Money spent on buybacks can’t be used to other ends, like capital investment or R&D. Lawmakers critical of the industry, meanwhile, have raised questions about why pharma companies have used savings from the recent tax cuts for buybacks rather than lowering drug prices.
recent article from The Wall Street Journal, for example, reported that 16 Democratic representatives have sent letters to drugmakers seeking answers and may request additional information or hold Congressional hearings next year.
That same report found eight of 10 pharma companies it analyzed increased stock buybacks in 2018 over their 2017 amounts. AbbVie has been one of the most aggressive in doing so, along with Amgen, Pfizer and Celgene.
Companies have increased capital investment following the tax overhaul, too, but many plan to spread out spending over multiple years and details remain vague on what such plans will actually entail.
It’s also not clear if buybacks accomplish what the companies intend.
In a recent analysis, Leerink analyst Geoffrey Porges concluded that stock buybacks conducted by six major drugmakers, including AbbVie, actually destroyed value and generated no positive return over a five-year period.
“In an industry characterized by large dominant products of finite duration and with very few sustainable sources of competitive advantage, we believe investors should view buybacks with caution, and possibly regard them as value destroying,” Porges wrote.
“Buybacks make sense in the context of long duration predictable cash flows that are unreasonably discounted at the prevailing stock price; they don’t make sense in the context of a wasting asset of fixed duration and finite potential, which increasingly characterizes biotech companies,” he continued.
AbbVie, for example, spent a total of $15.3 billion on stock buybacks between 2014 and 2018 that generated a negative 1% return as measured by the company’s share price at the end of October.
So far this year, shares in AbbVie are down about 10%.
Still, share buybacks could remain an attractive and predictable choice, particularly if a company finds M&A too pricey or too risky.

Teva to move global HQ to Tel Aviv amid $3B cost-cutting drive

Teva has already decided to move its U.S. headquarters, and now it’s planning to move its worldwide headquarters, too.
The company will relocate to Tel Aviv from Petah Tikvah, Israel in mid-2020, a spokeswoman confirmed by email. Teva has chosen a site in the city’s Ramat Hahayal district, and the new structure will house only Teva employees. Teva will be leasing the building.
The reasoning behind the move is no surprise, given the generics giant is in the midst of implementing a $3 billion cost-cutting drive. Putting Teva’s headquarters under one roof—instead of at sites scattered around Petah Tikva—will save the company money, the spokeswoman said.
“Combining into one site … will be an efficient and cost-effective solution, generating significant savings from a business and operations point of view,” she wrote, adding that it will also “fulfill our goal of working as One Teva.”

As part of CEO Kåre Schultz’s grand restructuring, unveiled this time last year to help the company out of immense debt, Teva also agreed this summer to an address change in the U.S. after shuttering pricey offices in New York and Washington, D.C. Lured by a $40 million tax break from the state of New Jersey, the company switched its home base to Parsippany from North Wales, Pennsylvania.
There, it has a construction project to complete. “It is an astronomical build-out process,” Harvey Rosenblatt, founder of the real estate developer that owns and manages Teva’s new building, toldNJ.com in July.
Meanwhile, as Globes pointed out, the Tel Aviv news is likely to go over well in Israel’s home country, where concerns have persisted—thanks in part to the hiring of Danish Schultz, as well as plenty of local layoffs—that Teva is losing its Isareli identity and could even relocate to a new country.

Lilly to Acquire Pre-Clinical Pain Program From Hydra Biosciences


Eli Lilly and Co. (LLY) on Friday said they would acquire all the assets of a pre-clinical pain program from Hydra Biosciences.
Eli agreed to acquire all assets related to Hydra’s pre-clinical program of TRPA1 antagonists, currently being studied for the potential treatment of chronic pain syndromes.
Financial terms of the deal weren’t disclosed.
“At Lilly, we are committed to developing new treatment options for people struggling with chronic pain,” said Dr. Mark Mintun, vice president of pain and neurodegeneration research at Lilly. “Through the acquisition of this promising pre-clinical program from Hydra, we will advance our understanding of the TRP pathway in pain signaling, and will seek to initiate clinical studies in the near term.”
Lilly said there would be no change to the company’s 2018 non-GAAP earnings per share guidance as a result of this transaction.

Physician Exclusions From Medicare, Medicaid Increasing


Federal efforts to detect Medicare fraud may be driving an increase in the number of physicians excluded from Medicare and other forms of public insurance, according to the authors of a newly published study.
The number of physicians excluded from Medicare, Medicaid, and other state public insurance programs increased on average by 20% per year, or the equivalent of 48 additional cases a year, between 2007 and 2017, said Anupam B. Jena, MD, PhD, of Harvard Medical School and colleagues. They report their findings in an article published online today in JAMA Network Open.
“There were several explanations for the observed increase in exclusions, and rates of identified health care fraud, waste, and abuse,” Jena and colleagues write. “First, this finding could be evidence that regulators, who have been aided by recent public policies targeting the reduction of fraud and waste, may be getting better at identifying perpetrators of fraudulent activity.”
Since 2011, the Centers for Medicare & Medicaid Services has used predictive analytics to detect improper billing, the authors note. In addition, the Affordable Care Act of 2010 allocated $350 million to the Department of Health & Human Services’ Health Care Fraud and Abuse Control Account. The law also increased sanctions, including allowing state Medicaid programs to halt payments and requiring that Medicare overpayments be returned within 60 days instead of 3 years.
Jena and colleagues also cite the growth in the total number of US physicians participating in public insurance as a possible cause for the rising number of exclusions.
The implementation of the Affordable Care Act of 2010 allowed more people to gain access to public insurance programs. Enrollment in any government health insurance plan increased by 12.6% total from 2013 to 2017, which is significantly greater than the 7.9% increase in private insurance enrollment, the authors note.
“We cannot exclude the possibility that the increase in physician exclusions reflects a rise in fraudulent and untoward practices by US physicians,” the authors add. “However, we are unaware of any published data that support this potential explanation.”
Overall, the researchers found that 2222 physicians, or 0.3% of US physicians, were temporarily or permanently excluded from Medicare and state public insurance programs between 2007 and 2017 for fraud, unlawful prescribing of controlled substances, or health crimes.
Physicians can be excluded from Medicare and other public insurance programs for a variety of reasons. Common causes include the illegal distributing, prescribing, and dispensing of controlled substances such as opioids and surgical anesthetics. Other reasons include billing for services not rendered and filing duplicate claims and providing medically unnecessary procedures.
Jena and colleagues describe their study as “the most comprehensive and contemporary effort to assess trends in physician exclusion from participation in public health insurance owing to fraud, waste, and abuse concerns, and physician characteristics associated with exclusion.”
For the analysis, they matched each physician’s unique national provider identifier to their profile in Doximity, an online networking service that collects personal and professional information about physicians.
The authors found notable variation in the rates of exclusion, which were highest in the West and Southeast. With 32 exclusions among 5720 physicians, West Virginia had the highest rate of exclusions at 5.77 per 1000. Montana, in contrast, had 0 exclusions during the study period.
“Several physician characteristics, including being a male, older age, and osteopathic training, were significantly and positively associated with exclusion,” the authors said.
This project was funded by National Institutes of Health grants. Jena also reported having received consulting fees from Pfizer, Hill Rom Services, Bristol Myers Squibb, Novartis, Amgen, Eli Lilly, Vertex Pharmaceuticals, AstraZeneca, Celgene, Tesaro, Sanofi Aventis, Biogen, Precision Health Economics, and Analysis Group outside the work reported in the paper.
JAMA Network Open. Published online December 14, 2018. Full text